Sunday, March 11, 2012

Introducing RxISK.org - a game changer for reporting adverse events

Why RxISK.org?

Prescription drug safety is an issue for us all.

Adverse side effects from these drugs are now a leading cause of death. And yet experts estimate that only 1–10% of “serious” adverse events (those that lead to hospitalization, life threatening, disability, congenital abnormality, and death) are ever reported. Not to mention the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s concentration, functioning, judgment, and ability to care.

RxISK.org, the first free website (not sponsored by big pharma or advertising) for patients and their doctors and pharmacists to research, and more importantly, easily report drug side effects.

Why Should You Report?

No one knows drug side effects like the person who is taking a pill. Yet this voice is not heard. RxISK.org provides a megaphone to you and your healthcare team to change the way we see drug safety.

You may have been told there is no evidence linking the treatment you are on to the problems you are experiencing. One reason there may be no evidence is because you and your doctor have been silenced. Most of the data on prescription drugs is “owned” by the multinational pharmaceutical companies who run 90% of all clinical drug trials — and they’re not sharing data that may affect their bottom lines. And, as mentioned above, only 1-10% of serious adverse events are reported to the FDA.

There is definitely a gap in the data — and we need data for Data Based Medicine.

This is where you and your doctor and pharmacist come in.

We encourage you to use RxISK.org to research prescription drugs and their side effects. But please consider also reporting your side effects. Not only will you be helping yourself — by receiving your free RxISK Report™ to take to your doctor or pharmacist — but you will also be helping others, by adding your anonymized experience to the data on prescription drugs.

RxISK.org is your website to help make medicines safer for all of us.

Our Mission

“We’ve talked about it – and now we’re doing something about it.”

Our goal is the early identification of potential adverse drug events and other treatment-related effects through a unique approach to data collection and analysis.

We believe RxISK.org will succeed because of

patients’ desire to have their situation considered by a site backed by an expert team;

a commitment to the truth, with no bias;

the necessary level of expertise in designing and interpreting patient information as it expands beyond simple yes-no answers; and

a single focus — that is, effective adverse-drug-event reporting must be the main mission, not a secondary one.

This will result in a collection of patient and medical narratives, including economic and quality of life information, that will establish the nature of treatment-related effects, the best methods to manage them, and their potential to form a basis for new drug discovery.

Now that the truth about such medications as Vioxx and Avandia has reached the public sphere, the general public is suspicious of messages from drug companies. Appetite for a credible independent perspective based on the voice of the patient is strong.

Our Medical and Research Team

There are few professionals who have the profile and international reputation of Data Based Medicine’s founding team, which includes people who have risked their careers in speaking out about adverse drug events, such as David Healy and Nancy Olivieri, as well as international experts on pharmaco-vigilance such as Ralph Edwards from World Health Organization’s Uppsala Monitoring Center.

Dr. David Healy, Chief Executive Officer and principal founder of Data Based Medicine Limited, is an internationally respected psychiatrist, psychopharmacologist, scientist, and author. A professor of Psychiatry at Cardiff University in Wales, David is a former Secretary of the British Association for Psychopharmacology, and has authored more than 150 peer-reviewed articles, 200 other pieces, and 20 books.

David has been involved as an expert witness in homicide and suicide trials involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghost-writing their articles. His latest book, Pharmageddon, documents the riveting and terrifying story of how pharmaceutical companies have hijacked healthcare in America and the life-threatening results.

Dr. Derelie Mangin is Professor and Director of Research in the Department of Public Health and General Practice in the University of Otago in New Zealand and an expert advisor to the NZ government on drug treatment funding priorities.

Dr. Kalman Applbaum is Professor of Medical Anthropology and Global Studies at the University of Wisconsin. He is a pharmaceutical industry expert and former marketing professor at the Kellogg School of Management.

Dr. Ralph Edwards was Director of the Uppsala Monitoring Centre (UMC) from 1990 to 2009. UMC is a World Health Organisation (WHO) collaborating centre for international drug monitoring located in Sweden. Under his management, revenue grew to in excess of US$40m. He has been President of the International Society of Pharmacovigilance (2000-2004) and is among the world’s leading experts on pharmaco-vigilance.

Dr. Brenda Gallie is Director of the Retinoblastoma Program at The Hospital for Sick Children, and Professor of Ophthalmology, Molecular Genetics, and Medical Biophysics at the University of Toronto. Her research has revealed basic molecular processes in cancer. She has developed a time-line for medical adverse events to enable patients and doctors to better understand how the adverse event might have evolved — this is incorporated into RxISK.

Robert Whitaker is the founder of Centerwatch (in 1994), an early provider of market intelligence on pharmaceutical companies for investment analysts and others. He is the author of Mad in America and Anatomy of an Epidemic, which analyze the consequences of the indiscriminate use of medications. Robert also publishes through his blog, Mad in America, and on Twitter @WhitakerRB.

Dr. Joanna Le Noury is Senior Research Scientist in the North Wales Department of Psychological Medicine; she has analyzed several large pharmaceutical databases in the course of litigation.

Dr. Nancy Olivieri is a Senior Scientist at Toronto General Hospital, and a Professor of Pediatrics, Medicine, and Public Health Sciences at the University of Toronto. Her work explores the role of the pharmaceutical industry in society, and its influence on research and on the evidence base of medicine.

Our Business Team

Peter Wood, FCA, is an Ernst & Young retired partner with expertise in tax, corporate management, and leading-edge technology who has developed several successful web-based businesses. We are fortunate to have Peter leading our business team of operations, finance, marketing, technology, and design professionals.

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Call me Jack

The term "PR" means something completely different to a medical doctor!
"We are all born ignorant, but one must work hard to remain stupid." -Benjamin Franklin.
"It takes a wise doctor to know when not to prescribe."
- Gracian.